Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04992897
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2021-07-04
Brief Title:
Real-world Data Analysis of REN Treatment in Migraine Patients
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
Real-world Analysis of Remote Electrical Neuromodulation REN for the Acute Treatment of Migraine
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Data analysis concerning four sets of metrics A Per-treatment patterns of REN use as a standalone treatment vs in combination with medications B Per-user Intra-individual consistency of efficacy across multiple treatments consistency defined as a response to treatment in at least 50 of treatments C Distribution of treatment intensity among users the electroceutical equivalent to treatment dose D Prevalence and severity of adverse events
Detailed Description:
The REN device The REN device is a wearable device applied to the upper arm and stimulates C and Aδ noxious fibers using a modulated symmetrical biphasic square pulse with a pulse width of 400 μs modulated frequency of 100-120 Hz and up to 40 mA output current which can be adjusted by the patient
Data collection As part of the sign-up process to the Nerivio app all patients accept the terms of use which specify that providing personal information is done of their own free will and that their de-identified data may be used for research purposes Users were not obligated to provide personal information and could treat without providing any feedback The app includes a secured personal migraine diary which enables patients to record and track their migraines and other headaches At the beginning of each treatment and again 2 hours after the start of treatment patients are prompted to record their symptoms including pain level none mild moderate severe functional disability No limitation Some limitation Moderate limitation Severe limitation and indication of which medications if any were taken within that 2-hour time window
Dataset Real-world data of REN treatments collected from patients across the United States who used the REN device
Treatment defined as a REN treatment of at least 20 minutes the nominal duration is 45 minutes
Evaluable treatment defined as a treatment in which pain levels were reported at baseline and post 2 hours
Inclusion criteria for each of the different metrics
A REN-medication combinations all evaluable treatments B Consistent efficacy all users that performed at least 2 evaluable treatments In order to isolate the effect of REN treatments this dataset considered only treatments where REN was used as a standalone treatment
C Intensity stability all treatments D Safety all reported adverse events AEs within the time period
Outcome measures
Respectively outcome measures
A REN-Medication combinations prevalence efficacy
Medication intake outcomes calculated based on the 2h post-treatment report and comprised of the percentage of treatments in which no rescue medications were used treatments in which OTC medications were taken treatments in which triptans were taken treatments in which other prescription medications were taken and treatments in which medication intake status was not reported OTC included acetaminophen NSAIDs and combinations of the two with or without caffeine
Efficacy outcomes calculated based on the baseline and post-2h reports and comprised of
i consistency of pain relief decrease in headache from moderate or severe at baseline to mild or no pain ii consistency of pain-freedom decrease in headache from mild moderate or severe at baseline to no pain iii Consistency of improvement in function improvement in at least one grade between baseline and 2 hours and iv consistency of return to normal function no functional disability at 2 hours
B Consistent efficacy
Consistency defined as a response of a patient to the treatment in at least 50 of their treated attacks and calculated for the four efficacy outcomes i consistency of pain relief ii consistency of pain-freedom iii consistency of improvement in function and iv consistency of return to normal function
C Treatment intensity
The mean intensity of the stimulation collected for all treatments that were 20 minutes or longer which were performed within the studys time window
D Safety
All adverse events that were reported within the studys period the following information provided number of device-related AEs percentage of the device-related AEs that were mild moderate and severe and percentage of AEs that were serious vs not serious
Data collection As part of the sign-up process to the Nerivio app all patients accept the terms of use which specify that providing personal information is done of their own free will and that their de-identified data may be used for research purposes Users were not obligated to provide personal information and could treat without providing any feedback The app includes a secured personal migraine diary which enables patients to record and track their migraines and other headaches At the beginning of each treatment and again 2 hours after the start of treatment patients are prompted to record their symptoms including pain level none mild moderate severe functional disability No limitation Some limitation Moderate limitation Severe limitation and indication of which medications if any were taken within that 2-hour time window
Dataset Real-world data of REN treatments collected from patients across the United States who used the REN device
Treatment defined as a REN treatment of at least 20 minutes the nominal duration is 45 minutes
Evaluable treatment defined as a treatment in which pain levels were reported at baseline and post 2 hours
Inclusion criteria for each of the different metrics
A REN-medication combinations all evaluable treatments B Consistent efficacy all users that performed at least 2 evaluable treatments In order to isolate the effect of REN treatments this dataset considered only treatments where REN was used as a standalone treatment
C Intensity stability all treatments D Safety all reported adverse events AEs within the time period
Outcome measures
Respectively outcome measures
A REN-Medication combinations prevalence efficacy
Medication intake outcomes calculated based on the 2h post-treatment report and comprised of the percentage of treatments in which no rescue medications were used treatments in which OTC medications were taken treatments in which triptans were taken treatments in which other prescription medications were taken and treatments in which medication intake status was not reported OTC included acetaminophen NSAIDs and combinations of the two with or without caffeine
Efficacy outcomes calculated based on the baseline and post-2h reports and comprised of
i consistency of pain relief decrease in headache from moderate or severe at baseline to mild or no pain ii consistency of pain-freedom decrease in headache from mild moderate or severe at baseline to no pain iii Consistency of improvement in function improvement in at least one grade between baseline and 2 hours and iv consistency of return to normal function no functional disability at 2 hours
B Consistent efficacy
Consistency defined as a response of a patient to the treatment in at least 50 of their treated attacks and calculated for the four efficacy outcomes i consistency of pain relief ii consistency of pain-freedom iii consistency of improvement in function and iv consistency of return to normal function
C Treatment intensity
The mean intensity of the stimulation collected for all treatments that were 20 minutes or longer which were performed within the studys time window
D Safety
All adverse events that were reported within the studys period the following information provided number of device-related AEs percentage of the device-related AEs that were mild moderate and severe and percentage of AEs that were serious vs not serious
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None